Jun 06, 2022

Quality Assurance Manager

$110,000 - $130,000 yearly
  • BiVACOR Inc
Full time Quality Regulatory

Job Description

BiVACOR is a young start-up eager to advance our products from laboratory to clinic. We are committed to establishing Quality Assurance practices that are supportive of our ongoing R&D activities. Now seeking a motivated team member to contribute to this dynamic project in our Cerritos Engineering Office. If you have strong organizational, leadership, and interpersonal skills then you should apply to join our energetic and diverse team.

The Quality Assurance Manager will work to develop and implement a quality management system in accordance with ISO 13485, 21 CFR 820, and MDR 2017/745. Strong preference will be given to candidates with hands-on, professional experience working with FDA Class III Medical Devices.

 

RESPONSIBILITIES

  • Lead development and implementation of in-house QMS
  • Lead planning and implementing good manufacturing practice (GMP) and good laboratory practice (GLP) systems
  • Co-leads (with R&D) in implementing Design Control:
    • Conduct risk assessments
    • Provide input and review of requirements and specifications and verification and validation testing for product, software, and processes
  • Refine policies using a Continuous Improvement Model
  • Manage staff and suppliers to ensure quality assurance policies and plans are followed:
    • Conduct quality assurance training
    • Perform internal surveillance audits
    • Perform supplier assessments and audits
    • Review SOPs and V&V testing
    • Prepare reports documenting compliance
  • Prepare and maintain technical files and documentation for EU and FDA submissions

REQUIREMENTS

  • Bachelor’s Degree in Electrical, Software, Industrial, Process, or Production Engineering preferred; postgrad qualification highly desirable (PhD or Master of Science, Engineering, or Business Administration)
  • Minimum 5 years in medical device development field – Ventricular Assist Device experience would be particularly highly valued
  • Minimum 3 years in quality assurance/management
  • Desirably holds certification/qualification from the American Society for Quality (CRE, CQE, CSQE, or CBA preferred), or Six Sigma Green Belt or higher, or similar
  • Proficient with Microsoft Office, project planning, and statistical software packages

Apply Now